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HHS/FDA

RIN: 0910-AF77

Publication ID: Spring 2008

Title: Natural Rubber-Containing Medical Device; User Labeling(Completion of a Section 610 Review)
Abstract: FDA has under taken a review of 21 CFR part 801 under section 610 of the Regulatory Flexibility Act. The purpose of the review was to determine whether the regulations in part 801 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA has solicited comments on the following (1) The continued need for the regulation in part 801; (2) the nature of complaints or comments received concerning the regulation in part 801; (3) the complexity of the regulation in part 801; (4) the extent to which the regulation in part 801 overlap, duplicates, or conflict with other Federal, State, or governmental rules: and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation in part 801. The section 610 review has been carried out along with a regulation review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive Order. The agency did not receive any comments during the review process of part 801 under section 610 review. FDA's review of this regulation concluded that it should be continued without change.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
RFA Section 610 Review: Completion of a Section 610 Review
CFR Citation: 21 CFR 801.437
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 357 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374

Legal Deadline:

Action	Source	Description	Date
Other	Statutory	Planned section 610 review	09/30/2007

Timetable:

Action	Date	FR Cite
Final Action	09/30/1997	62 FR 51021
Begin Review of Current Regulation	01/02/2007
End Review of Current Regulation	12/28/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov